Enzastaurin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Recruitment status was Active, not recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
RATIONALE: Enzastaurin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well enzastaurin works in treating patients with persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer Primary Peritoneal Cavity Cancer |
Drug: enzastaurin hydrochloride |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Evaluation of Enzastaurin (Lilly IND # 60, 933) in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma |
- Frequency of patients with 6-month progression-free survival (PFS) or objective tumor response [ Designated as safety issue: No ]
- Frequency and severity of adverse effects as measured by CTCAE v3.0 [ Designated as safety issue: Yes ]
- Duration of PFS and overall survival [ Designated as safety issue: No ]
- Prognostic factors, including platinum sensitivity, initial performance status, and age [ Designated as safety issue: No ]
| Estimated Enrollment: | 68 |
| Study Start Date: | November 2006 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- Assess the efficacy of enzastaurin hydrochloride, in terms of 6-month progression-free survival or objective tumor response, in patients with recurrent or persistent ovarian epithelial or primary peritoneal cancer.
- Determine the nature and degree of toxicity of this regimen in these patients.
Secondary
- Determine the duration of progression-free and overall survival of patients treated with this regimen.
- Determine the effects of prognostic variables, including platinum sensitivity, initial performance status, and age, in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive oral enzastaurin hydrochloride 3 times on day 1 and then once daily on days 2-28 of course 1. For all subsequent courses, patients receive enzastaurin hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 68 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically confirmed ovarian epithelial or primary peritoneal carcinoma
- Recurrent or persistent disease
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
Must have ≥ 1 target lesion to assess response
- Tumors within a previously irradiated field are designated as "nontarget" lesions unless progression is documented or a biopsy is obtained to confirm persistence ≥ 90 days after completion of radiotherapy
Must have received 1 prior platinum-based chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound for management of primary disease
- Initial treatment may have included high-dose therapy, consolidation therapy, or extended therapy administered after surgical or nonsurgical assessment
Must meet any 1 of the following criteria for platinum-based therapy:
- Disease progression during therapy
- Treatment-free interval after completion of treatment < 12 months
- Disease persistence after completion of therapy
- Ineligible for a higher priority GOG clinical trial
PATIENT CHARACTERISTICS:
- GOG performance status 0-1 (for patients who received 2 prior treatment regimens) OR 0-2 (for patients who received 1 prior treatment regimen)
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9 g/dL (transfusions allowed)
- Creatinine < 1.5 times upper limit of normal (ULN)
- Bilirubin ≤ 2 times ULN
- Alkaline phosphatase ≤ 3 times ULN (5 times ULN if liver metastases are present)
- AST and ALT ≤ 3 times ULN (5 times ULN if liver metastases are present)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- Able to swallow tablets
- No sensory or motor neuropathy > grade 1
- No active infection requiring antibiotics
- No other invasive malignancies or evidence of cancer within the past 5 years except nonmelanoma skin cancer
- No serious systemic disorders that would preclude study compliance, including an abnormal ECG indicative of cardiac disease
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from prior surgery, radiotherapy, or chemotherapy
- At least 1 week since prior anticancer hormonal therapy
- No more than 1 additional cytotoxic regimen for management of recurrent or persistent disease
- At least 4 weeks since other prior anticancer therapy, including immunotherapy
- At least 30 days since prior investigational drugs
- No prior enzastaurin hydrochloride
- No prior radiotherapy to > 25% of marrow-bearing areas
- No prior noncytotoxic therapy, including bevacizumab, for recurrent or persistent disease
- No prior treatment that would preclude treatment on this protocol
- No concurrent chemotherapy, immunotherapy, or other experimental medications
- No concurrent enzyme-inducing antiepileptic drugs, including carbamazepine, phenobarbital, or phenytoin
- No other concurrent systemic anticancer therapy
- No concurrent radiotherapy, including palliative radiotherapy
- No concurrent agents that stimulate thrombopoiesis
- No concurrent amifostine or other protective reagents
- Concurrent hormone replacement therapy allowed
- Concurrent bisphosphonates allowed provided bony metastases are present
Contacts and Locations| United States, California | |
| Jonsson Comprehensive Cancer Center at UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| United States, Illinois | |
| Rush University Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| Decatur Memorial Hospital Cancer Care Institute | |
| Decatur, Illinois, United States, 62526 | |
| Evanston Northwestern Healthcare - Evanston Hospital | |
| Evanston, Illinois, United States, 60201-1781 | |
| Hinsdale Hematology Oncology Associates | |
| Hinsdale, Illinois, United States, 60521 | |
| CCOP - Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| United States, Indiana | |
| St. Vincent Indianapolis Hospital | |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Michigan | |
| CCOP - Grand Rapids | |
| Grand Rapids, Michigan, United States, 49503 | |
| United States, Missouri | |
| Hulston Cancer Center at Cox Medical Center South | |
| Springfield, Missouri, United States, 65807 | |
| United States, Nebraska | |
| Methodist Estabrook Cancer Center | |
| Omaha, Nebraska, United States, 68114 | |
| United States, North Carolina | |
| Blumenthal Cancer Center at Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28232-2861 | |
| United States, Oklahoma | |
| Oklahoma University Cancer Institute | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Pennsylvania | |
| Rosenfeld Cancer Center at Abington Memorial Hospital | |
| Abington, Pennsylvania, United States, 19001 | |
| Fox Chase Cancer Center - Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19111-2497 | |
| McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center | |
| Reading, Pennsylvania, United States, 19612-6052 | |
| United States, Washington | |
| University Cancer Center at University of Washington Medical Center | |
| Seattle, Washington, United States, 98195-6043 | |
| Study Chair: | Lydia Usha, MD | Rush University Medical Center |
| Investigator: | Jean A. Hurteau, MD | NorthShore University HealthSystem Research Institute |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00407758 History of Changes |
| Other Study ID Numbers: | CDR0000517318, GOG-0170J, LILLY-H6Q-MC-S025 |
| Study First Received: | December 4, 2006 |
| Last Updated: | July 18, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by National Cancer Institute (NCI):
|
recurrent ovarian epithelial cancer primary peritoneal cavity cancer |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Peritoneal Neoplasms Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female |
Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 16, 2013